Kit, device and method for controlled delivery of oxidizing agent into the skin

• US 7,340,297 B2
• Filed: 06/02/2004
• Issued: 03/04/2008
• Est. Priority Date: 06/02/2003
• Status: Expired due to Fees

• Current Assignee: Power Paper Ltd. (Products To Go, Inc.)
• Original Assignee: Power Paper Ltd. (Products To Go, Inc.)
• Inventors: Arbel, Giora, Gross, Yossi, Nitzan, Zvi, Tamarkin, Dov, Mavor, Daniela, Luski, Shalom, Harel, Nurit
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US10/858,045
• Publication Number:
  US 20040267190A1
• Time in Patent Office: 1,371 Days
• Field of Search: 604/20, 424/78.07, 424/78.27, 424/62, 424/443, 424/449
• US Class Current: 604/20
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/12 Keratolytics, e.g. wart or anti-corn preparations
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A kit, device and method for delivering an oxidizing agent onto and/or into the body are disclosed. Moreover, a dermal patch device, which delivers an oxidizing agent using iontophoresis and or electroosmosis onto and/or into the body is disclosed. Furthermore, use of a dermal patch device for treatment of a body area with an oxidizing agent is disclosed. The device may be a thin and flexible dermal patch. A method of using such a device/kit for treatment of a disorder of a body area with an oxidizing agent is also disclosed.

Claims

1. A kit, comprising:

a formulation comprising at least one oxidizing agent precursor; and

an electrically powered patch to promote electrical conversion of the at least one oxidizing agent precursor into an active oxidizing agent and delivery of the active oxidizing agent onto and/or into a body area,

wherein the patch is configured to provide an electrical potential sufficient to generate the active oxidizing agent determined according to the standard potential of the oxidizing agent and/or oxidizing agent precursor.

2. The kit of claim 1, wherein the patch is an iontophoretic patch.

3. The kit of claim 1, wherein the patch comprises:

at least one active electrode;

at least one counter electrode; and

at least one power supply to supply electrical energy to the at least one active electrode and the at least one counter electrode, wherein the at least one power supply is supported on a base member.

4. The kit of claim 3, wherein the at least one power supply comprises at least one electrochemical cell.

5. The kit of claim 4, wherein the electrochemical cell is thin and flexible.

6. The kit of claim 4, wherein the electrochemical cell comprises:

a first layer of insoluble negative pole;

a second layer of insoluble positive pole; and

a third layer of aqueous electrolyte disposed between the first and second layers and including;

a deliquescent material to keep the electrochemical cell wet at all times;

an electroactive soluble material to obtain ionic conductivity; and

a water-soluble polymer to obtain a desired viscosity to adhere the first and second layers to the third layer.

7. The kit of claim 3, wherein the at least one oxidizing agent precursor is disposed in an interface area between the at least one active electrode and the at least one counter electrode.

8. The kit of claim 1, wherein the patch comprises at least one active electrode, and the at least one active electrode is at least one of an anode, a cathode or both an anode and a cathode and wherein the at least one oxidizing agent precursor is disposed on the at least one active electrode.

9. The kit of claim 1 further comprising a holding component that holds and stores the oxidizing agent formulation to contact a first region of the body area and the at least one active electrode.

10. The kit of claim 9, wherein the holding component is selected from the group consisting of a sponge, separator, non-woven material, or substrate base layer.

11. The kit of claim 1, wherein the at least one oxidizing agent precursor is applied directly to the body area.

12. The kit of claim 1, further comprising:

a conductive layer comprising a conductive composition to provide a conductive layer between the patch and the body area.

13. The kit of claim 12, wherein the conductive composition is a hydro gel.

14. The kit of claim 12, wherein the at least one oxidizing agent precursor is contained in the conductive composition.

15. The kit of claim 12, wherein the conductive layer is disposed on the at least one active electrode.

16. The kit of claim 1, wherein the body area is selected from the group consisting of skin, teeth, nails, hair, non-malignant growth, tumor and a combination thereof.

17. The kit of claim 1 for treatment of a disorder, wherein the disorder is selected from the group consisting of a bacterial infection, a viral infection, a fungal infection, a mucosal disorder, scaling diseases, tumors, body area discoloration and a combination thereof.

18. The kit of claim 1, wherein the patch is thin and flexible.

19. The kit of claim 1, wherein the patch is a printed patch.

20. The kit of claim 1, further comprising an additional active medicinal ingredient.

21. The kit of claim 1, wherein the current density of the electrical potential and/or the concentration of the at least one oxidizing agent precursor is positively correlated with the amount of the active oxidizing agent.

22. The kit of claim 1 for treatment of a fungal infection of the nail.

23. A device comprising:

at least one first electrode adapted to communicate an active substance into a body area by application of an electrical current on a body surface adjacent to the body area;

at least one second electrode, facilitating closing of electrical circuit with the body surface;

at least one power source to provide a current and voltage, connected through a conductive media to the first and second electrodes; and

at least one oxidizing agent precursor,

wherein the device is configured to provide an electrical potential sufficient to generate an active oxidizing agent from the at least one oxidizing agent precursor determined according to the standard potential of the oxidizing agent and/or oxidizing agent precursor and deliver the active oxidizing agent onto and/or into a body area.

24. The device of claim 23, further comprising a holding component for holding the at least one oxidizing agent precursor.

25. The device of claim 24, further comprising a conductive layer comprising a conductive composition disposed between the patch and the body area, for providing a conductive interfacing layer between the patch and the body area, wherein the conductive layer is disposed on at least one of the group selected from the first electrode, the second electrode and the first and the second electrode, the holding component, the body area surface and a combination thereof.

26. The device of claim 25, wherein the conductive composition comprises the at least one oxidizing agent precursor.

27. The device of claim 23, wherein the at least one oxidizing agent precursor is mixed within the material of one or both of the at least one first and the at least one second electrodes.

28. The device of claim 23, wherein the at least one oxidizing agent precursor is disposed in an area between the first electrode and the second electrode.

29. The device of claim 23, wherein the electrical voltage and current facilitate conversion of the at least one oxidizing agent precursor into an oxidizing agent.

30. The device of claim 23, wherein the electrical voltage and current facilitate delivering the oxidizing agent, topically or via iontophoresis, to the body surface.

31. The device of claim 23, wherein the power supply comprises at least one thin and flexible electrochemical cell.

32. The device of claim 23, wherein the patch is thin and flexible.

33. The device of claim 23, wherein the electrodes and power source are applied using a printing technology onto the patch substrate.

34. The device of claim 23, further comprising a substrate base layer.

35. A method of treating a body area with an oxidizing agent comprising:

converting electrically at least one oxidizing agent precursor into an oxidizing agent by providing an electrical potential sufficient to generate an active oxidizing agent determined according to the standard potential of the oxidizing agent and/or at least one oxidizing agent precursor; and

delivering iontophoretically the resulting oxidizing agent, facilitating oxidizing agent penetration of the body area surface and underlying tissues and treatment of the body area.

36. A device comprising:

at least one first electrode adapted to communicate an active substance into a body area by application of an electrical current on a body surface adjacent to the body area;

at least one second electrode, facilitating closing of electrical circuit with the body surface;

at least one power source to provide a current and voltage, connected through a conductive media to the first and second electrodes; and

an oxidizing agent precursor for generating in situ an oxidizing agent for treatment of a body area

wherein the generated oxidizing agent is the active substance.

37. The device of claim 36, wherein the oxidizing agent is electrochemically generated.